The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC

• ClinicalTrials.gov Identifier: NCT03807219
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Sponsor: Naveh Pharma LTD
• Information provided by (Responsible Party): Naveh Pharma LTD

Study Description

Brief Summary:

A randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in the parallel groups to determine the efficacy and safety of a 60-day use of the dietary supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps

Condition or disease	Intervention/treatment	Phase
Nocturnal Leg Cramps	Dietary Supplement: Magnox Comfort; Other: Placebo	Not Applicable

Detailed Description:

At the beginning of the study, study subjects undergo a 14-day screening period during which the number of episodes of NLC is recorded. For further participation in the study, they must have at least 4 NLC episodes. Thereafter, an examination of compliance with the study requirements is performed and study subjects are randomized to one of the two groups: for a 60-day of IP use (1 capsule of Magnox Comfort daily) or to the control group (1 capsule of placebo daily).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Prospective, Double-blind, Placebo-controlled, Clinical Trial in the Parallel Groups to Determine the Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
• Actual Study Start Date: February 9, 2018
• Actual Primary Completion Date: August 27, 2018
• Actual Study Completion Date: August 27, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Magnox Comfort; 80 subjects will be on the Magnox Comfort arm.	Dietary Supplement: Magnox Comfort; Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
Placebo Comparator: Placebo; 80 subjects will be on the Placebo arm.	Other: Placebo; placebo

Outcome Measures

Primary Outcome Measures :

1. The number of episodes of NLC [ Time Frame: The difference in count of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day. ]
   The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary

Secondary Outcome Measures :

1. Duration of NLC [ Time Frame: The difference in duration of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day. ]
   The study subject will record the length of cramps in the diary
2. Severity of pain associated with NLC [ Time Frame: The difference in severity of pain of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day. ]
   The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10
3. Change in quality of life (SF-36) [ Time Frame: The difference in quality of life documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day. ]
   Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation.
4. Changing in the sleep quality [ Time Frame: The difference in sleep quality documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day. ]
   The evaluation will be conducted using VAS (visual analog scale) from 0 to 5
5. Drop-out rate [ Time Frame: The difference in drop-out rate documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day. ]
   Counts of drop-out subjects

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
2. A study subject is a man or a woman over the age of 45 years;
3. The study subject has an established diagnosis of the nocturnal legs cramps;
4. The study subject understands the Ukrainian language;
5. The study subject has satisfactory results of the neurological examination of both lower extremities;
6. The study subject has a telephone and can use it permanently;

Exclusion Criteria:

1. The onset of one of the non-inclusion criteria;
2. The study subject has less than 4 episodes of NLC during the 14-day screening period;
3. There is necessity for significant change in the treatment tactics.

Contacts and Locations

Locations

Ukraine

Kharkiv City Clinic №9

Kharkiv, Kharkiv Region, Ukraine

Kyiv city clinic №9

Kyiv, Kyiv Region, Ukraine

Medical Center "Artem"

Kyiv, Kyiv Region, Ukraine

Medical Center "Preventclinic" LLC

Kyiv, Kyiv Region, Ukraine

City clinic №5

Lviv, Lviv Region, Ukraine

Odesa Railway City Clinic

Odesa, Odesa Region, Ukraine

Medical center "Desna" LLC

Ternopil', Ternopil' Region, Ukraine

Sponsors and Collaborators

Naveh Pharma LTD

Investigators

• Study Director: Nitsan Primor; Naveh Pharma LTD

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps. Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.

• Responsible Party: Naveh Pharma LTD
• ClinicalTrials.gov Identifier: NCT03807219
• Other Study ID Numbers: FS-MAG-1907
• First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naveh Pharma LTD:

nocturnal legs cramps; legs cramps; NLC

Additional relevant MeSH terms:

Sleep-Wake Transition Disorders; Nervous System Diseases; Parasomnias; Sleep Wake Disorders; Mental Disorders